FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994
Assessment of current:
- Policies and practices.
- Procedures and work instructions.
- Quality records.
- Process diagram from design to service of the medical device(s).
- Quality Policy and Quality Manual to comply with the CDRH/FDA and ISO 13485
- Processes that comply with Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), requirements and ISO 13485 Quality System standards.
- Standard operating procedures (SOPs) and work instructions (WIs) that comply with the QSR and ISO 13485 and to assure control of the quality, safety and effectiveness of the medical device(s).
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